Lianhua Qingwen capsule for the treatment of H1N1 Flu: a double blinding and muti-central randomized placebo-controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-09000590

Enrollment

Unknown

Registered

2009-10-31

Start date

2009-10-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

H1N1 flu

Interventions

Group A:Lianhua Qingwen capsule 2.4g three times a day orally

Group B:Placebo 2.4g three times a day orally

Eligibility

Sex/Gender

All

Age

16 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients with H1N1 flu confirmed by virology (According to the 3rd version of Diagnosis and Treatment Protocol of H1N1 flue, released by Health ministry of People's republic of China, 2009); 2. Patients aged 16 to 65 years old of both gender; 3. Axillary temperature >=37.4 degree C and with at least symptoms including cough, sore throat, headache, myalgia, fatigue, nasal obstruction, running nose, et al.; 4. Disease course was within 36 hours and no other drug for flu was used; 5. Voluntarily signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with severe disease, such as cardiovascular, cerabrovasular, hepatic, renal and hematopoietic system disease; 2. Patients with psychiatric disease; 3. Patients with Pharynx – conjunctivitis, Acute obstructive laryngeal - tracheal – bronchitis, Bronchiolitis, pneumonia, Active pulmonary tuberculosis, Bronchiectasis or other pulmonary disease. 4. Allergy to Lianhua qingwen Capsule or other drugs for treatment of H1N1 Flu. 5. Patients under 19 years old use Aspirin for a long time; 6. Patients received H1N1 flue vaccine; 7. Female patients with a positive result in Urine pregnancy test; 8. Extreme obese patients (BMI>=40); 9. Patients participated in other clinical trial within 1 month; 10. Patients with any other reason that was not suitable for this trial judged by clinical doctors.

Design outcomes

Primary

Measure	Time frame
Time to relief of flu-like symptom;	—

Secondary

Measure	Time frame
Hospital stay;Symptom score of Traditional Chinese Medicine;Time to relief of single flu symptom;Time of Fever Clearance;Viral nucleic acid overcas;	—

Countries

China

Contacts

Public ContactZhongping Duan

duan2517@163.com+86 10 63291007

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026